Computed tomography (hereinafter “CT”) is a medical procedure whereby an X-ray imaging machine is used to take cross-sectional images of a patient. The source of the X-rays is placed on one side of the body while an array of detectors is placed on the other side. The X-rays pass through the body and are read by the detectors on the other side. The signals received by the detectors are sent to a computer which compiles the data to create images. The detectors and X-ray source may be rotated around the body, while the body is being translated axially, to create a plurality of layered images.
CT differs from traditional X-ray imaging in that a computer is used to first “record” the image. Often, a contrast agent providing radiopaque contrast is injected into the patient intravenously to greatly enhance the images. Because the nature of CT is more like a continuous “movie” rather than a snapshot-like traditional X-ray, the flow and efficacy of the contrast agent may be monitored during the procedure.
Using radiopaque contrast agents for CT procedures, however, involves complications. For example, extravasation, the unintentional delivery of an injectate into the tissue surrounding the targeted vein or artery, can be a serious complication when injecting a radiopaque contrast agent during a CT procedure. These contrast agents are relatively thick solutions that are not easily absorbed by human tissue. Thus, whereas extravasation of an easily-absorbed solution, such as saline, is of relatively minor consequence, extravasation of a CT contrast agent can be a painful mishap often requiring an invasive, surgical removal procedure called a fasciotomy.
Extravasation occurs whenever the tip of the percutaneous needle is not located in the target vein and injectate is nonetheless delivered through the needle. There are various causes of extravasation. One cause involves a technician or nurse missing the lumen of the target vein, or passing completely through the vein with the needle tip, during introduction. Another cause involves the jetting force of the injectate creating a rearward, resultant force on the needle, pushing the needle out of the vein, or pushing the vein away from the needle tip until the tip is no longer in the lumen. Extravasation may also be caused by the jet force of the injectate eroding through the wall of the vessel.
Manual control of the injection flow rate by a skilled technician would effectively minimize extravasation caused by excessive jetting force. However, as previously mentioned, contrast agent continues to be injected into the vein during a CT procedure. A technician manually injecting the agent would thus be exposed to repeated, and cumulatively harmful, doses of X-ray radiation.
The need for precise control over the flow rate of CT contrast agent, along with the hazards of repeated exposure to X-ray radiation, has illuminated the need for the development of a computer controlled, automatic injector system. The applicants have developed a somewhat similar system for use in angiographic procedures. This system is described in U.S. Pat. No. 6,099,502, filed Oct. 24, 1997, and U.S. patent application Ser. No. 09/542,422, filed Apr. 4, 2000, both of which are incorporated herein by reference in their entireties.
Angiograms are similar to CT scans in that the same contrast agent is used to form an X-ray image. However, angiograms do not share many of the complications of CT scans. Angiograms involve the introduction of a long catheter into the aorta through an entry in the groin. The catheter is threaded through the aorta to the target site, such as the heart or brain, and used to deliver a larger volume of injected contrast agent in a short time. The goal is to create a slug of contrast agent that occupies substantially the entire lumen of the target site in order to form an image of the targeted vascular system. Once the agent is injected, a series of traditional X-rays are taken. If it is determined that more X-rays are needed, another slug of contrast agent is injected. Thus, extravasation is much less likely to happen as the catheter is positioned deep within the aorta and the location of the distal end is established before the agent is introduced. Further, there is sufficient time between the introduction of the agent and the taking of the X-rays for the attending physician and technicians to leave the X-ray room.
The aforementioned injector system was developed because technicians were unable to achieve the necessary injectate flow rate manually. However, this system is unsuitable for CT agent introduction. In addition to being too large, it requires the technician to be present in the X-ray room during operation.
It would be desirable to develop an automated injector system tailored to the unique needs of CT. Such a system would optimally provide remote operation, redundant safeguards against uncontrolled agent introduction, and the ability to alternate between two injectates. A need for a method of injecting a radiopaque contrast agent that reduces the risk of contrast agent extravasation is also needed.